Efficacy and Safety Study of Advantan for Maintenance Treatment of Atopic Dermatitis
Purpose of the study:
One bothering feature of atopic dermatitis is its relapsing nature. Hence, it is worthwhile to test modes how to efficiently prevent relapses or at least increase the time until the disease recurs. In order to give recommendations to other patients, this study is to scientifically describe efficacy and safety of a given regimen, namely a maintenance therapy with two days a week Advantan.
|Dermatitis, Atopic||Drug: Methylprednisolone Aceponate (Advantan, BAY86-4862) Drug: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Double-Blind, Placebo Controlled, Randomized, Multicenter, Parallel-Group Study to Compare the Efficacy and Safety of Advantan Cream Twice Weekly With Advabase Cream During a Maintenance Phase of 16 Weeks After Successful Treatment of Atopic Dermatitis With Advantan Cream|
- Time to relapse in the maintenance phase (MP) [ Time Frame: Week 16 ]
- Patients' number of relapses in the maintenance phase [ Time Frame: Week 16 ]
- Treatment success as assessed by Investigator Global Assessment (IGA) score [ Time Frame: Week 16 ]
- Percentage change during Acute Phase (AP) and MP assessed by Modified Eczema Area and Severity Index (mEASI) [ Time Frame: Week 16 ]
- Index lesion monitoring [ Time Frame: Week 16 ]
- Change of disease during AP and MP as assessed by Patient Global Assessment [ Time Frame: Week 16 ]
- Visual assessment of signs of atrophy [ Time Frame: Week 16 ]
- Ultrasound for measurement of skin thickness in selected sites [ Time Frame: Up to week 16 ]
- Dermatology Life Quality Index (CDLQI, DLQI) [ Time Frame: Week 16 ]
- Adverse Event Collection [ Time Frame: Week 16 ]
|Study Start Date:||March 2005|
|Study Completion Date:||June 2006|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
|Experimental: Arm 1||
Drug: Methylprednisolone Aceponate (Advantan, BAY86-4862)
In maintenance phase, Methylprednisolone Aceponate cream is applied topically twice a week.
|Placebo Comparator: Arm 2||
2 days a week Vehicle (Advabase)
The study has initially been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Intendis GmbH, a Bayer HealthCare company, is the sponsor of the trial.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185510
|Study Director:||Bayer Study Director||Bayer|